Keeping Track: A Busy Week For Regenerative Medicine, A Surprise Priority Review For Vascepa, And Tazemetostat Aims For Accelerated Approval
The latest drug development news and highlights from our US FDA Performance Tracker.
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Ahead Of Ryoncil’s Advisory Committee, Citizen Petition Opposes Approval For Pediatric GVHD
Lawyer asks US FDA to require another trial before licensing Mesoblast’s stem cell therapy for children with SR-aGVHD; Incyte’s Jakafi is only product approved for the indication.
Mesoblast, Athersys Take Lead In Race To Develop Stem Cell Therapies For COVID-19
Phase II/III studies are underway for Mesoblast’s remestemcel-L and Athersys’ Multistem, followed by a pack of earlier-stage stem cell candidates from Pluristem, Hope Bioscience and Celltex – with an interactive chart of the COVID-19 cell therapy pipeline.
Keeping Track: Oncology Submissions From Blueprint, Y-mAbs, BMS/bluebird; Approvals For BMS’ Reblozyl, LFB’s SevenFact
The latest drug development news and highlights from the Pink Sheet US FDA Performance Tracker.